Taiwan FDA registration 43649074541ab9815c5a3707ee4eaa8f

Abbott clinical biochemical second-generation total bilirubin test group

TW: 亞培臨床生化第二代總膽紅素檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Oct 19, 2022 – Oct 19, 2027Active
Registration details
Analysis ID
43649074541ab9815c5a3707ee4eaa8f
Customs Code
DHA05603586606
Company information
Manufacturer Country
Ireland
Product details
Intended Use
This product is used to quantify total bilirubin in human serum or plasma in adults and newborns on the ARCHITECT c System.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1110 Bilirubin (total or direct) test system
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 19, 2022
Expiry Date
Oct 19, 2027
About this record

Access comprehensive regulatory information for Abbott clinical biochemical second-generation total bilirubin test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 43649074541ab9815c5a3707ee4eaa8f and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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